Latitude
Radial Cut Guide
3manufacturers in China registered for this device type
1catalogue number
9510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Tornier Inc., United States |
|---|---|
| FDA product code | JDB |
| Device type | Prosthesis, Elbow, Semi-Constrained, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3160 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2019-05-08 |
| Record revised | 2024-04-26 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9030397 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tema Elbow | Limacorporate | 90 |
| Rhead | Stryker GmbH | 46 |
| Latitude EV™ | Tornier Inc. | 33 |
| Latitude™ – Elbow | Tornier Inc. | 22 |
| UNI-Elbow | Stryker GmbH | 20 |
| Tema Elbow System | Limacorporate | 9 |
| Sorbie Questor ™ | Wright Medical Technology, Inc. | 9 |
| AMK | Depuy Orthopaedics, Inc. | 8 |
| RHS – Radial Prosthesis | Tornier Inc. | 7 |
| AML TRI-Lock | Depuy Orthopaedics, Inc. | 2 |
| Acclaim | Depuy Orthopaedics, Inc. | 2 |
| Elite | Depuy Intl., Ltd. | 1 |
Showing 12 of 18. All products under Prosthesis, Elbow, Semi-Constrained, Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K193247 | 2020-08-05 |
| K182461 | 2018-12-27 |
| K171010 | 2017-08-31 |
| K100562 | 2010-06-29 |
| K070787 | 2007-08-24 |
| K060438 | 2006-04-18 |
| K050848 | 2005-07-14 |
| K031218 | 2003-05-16 |
| K011567 | 2001-06-19 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-03-03 | Class II | Under Investigation by firm | A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. ” Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect) ” Device Actually: 9030092, Humeral Stem Trial 150mm M | 5 units | |
| 2011-06-23 | Not classified | Process change control | Tornier has discovered that some models of the Tornier latitude Elbow Prosthesis (Small and Medium Humeral stems) were manufactured with a humeral screw that may not function as designed. | 3 | 2012-07-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.